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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 076979

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NDA 076979 describes CALCITONIN-SALMON, which is a drug marketed by Cipla, Custopharm Inc, Dr Reddys, Endo Operations, Igi Labs Inc, and Apotex Inc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the CALCITONIN-SALMON profile page.

The generic ingredient in CALCITONIN-SALMON is calcitonin salmon. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for 076979

Tradename:	CALCITONIN-SALMON
Applicant:	Endo Operations
Ingredient:	calcitonin salmon
Patents:	0

Pharmacology for NDA: 076979

Suppliers and Packaging for NDA: 076979

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITONIN-SALMON	calcitonin salmon	SPRAY, METERED;NASAL	076979	ANDA	Endo USA, Inc.	49884-161	49884-161-11	3.7 mL in 1 BOTTLE, GLASS (49884-161-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	200 IU/SPRAY
Approval Date:	Jun 8, 2009	TE:	AB	RLD:	No

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